ASHG supports Genetic Privacy Provisions in 21st Century Cures Act

BETHESDA, MD – The American Society of Human Genetics (ASHG) commends Congress for strengthening privacy protections for genetics research participants as part of the 21st Century Cures Act (H.R.34) passed on December 7. These provisions, Section 2012 and Section 2013 of H.R.34, were originally introduced in the Senate by Senator Warren (D-MA) and Senator Enzi (R-WY) as the Genetic Research Privacy Protection Act (S.2744), legislation endorsed by ASHG.

"Remarkable innovation in DNA sequencing technologies means that we can now conduct genomics research on a completely different scale from only a few years ago, resulting in large-scale programs like the Precision Medicine Initiative, which will include the analysis of the genomes of more than a million participants," said Derek Scholes, PhD, Director of Science Policy at ASHG. "In launching such research projects, it is important to protect the privacy of participants, who, in volunteering to participate, entrust researchers with their private, sensitive information."

Some of the newly passed protections build on existing certificates of confidentiality protections for research participants. These certificates allow research institutions to reject requests for individuals' research data from people or entities not involved in the research. Currently, researchers may request these certificates but are not under any obligation to do so. Under the new law, certificates of confidentiality will be issued automatically for research projects involving the collection of identifiable, sensitive research information.

In addition, the new provisions guard against inappropriate use of the Freedom of Information Act (FOIA) to gain access to participants' genetic and health information by allowing the Department of Health and Human Services to explicitly disqualify such individual-level research data from FOIA.

"With improved protections, individuals can participate in research with increased confidence that their genetic and health information will remain private," said Hal Dietz, MD, President of ASHG. "The Society applauds the leadership of Senator Warren and Senator Enzi in establishing these protections."